DermaFilm Sacral - DERMARITE INDUSTRIES LLC

Duns Number:883925562

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More Product Details

Catalog Number

-

Brand Name

DermaFilm Sacral

Version/Model Number

00279E

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

NAD

Product Code Name

Dressing, Wound, Occlusive

Device Record Status

Public Device Record Key

243c2fe4-6687-4d89-b0bc-7219b0d56f70

Public Version Date

September 17, 2021

Public Version Number

1

DI Record Publish Date

September 09, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DERMARITE INDUSTRIES LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 137
U Unclassified 36